跳至主要内容
临床试验/NCT01099605
NCT01099605撤回不适用

Continuous Infusion of Local Anesthetic for Optimal Post Operative Pain Control Following Hemorrhoidectomy: A Randomized Double-blind Controlled Trial

United States Naval Medical Center, Portsmouth1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2010年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
7
试验地点
1
主要终点
VAS pain scales

研究概览

简要总结

Over the past decade, continuous wound infiltration systems have been introduced to treat a variety of post-surgical pain. These systems, commonly referred to pain pumps by patients, possess a catheter(s) attached to a reservoir of local anesthetic that directly infuses into the surgical site to provide local pain control thus avoiding the common and less desirable systemic effects of oral narcotic pain medication. Due to its portability, another benefit associated with these wound infiltration systems is its use as an outpatient pain control modality. Despite the apparent benefits, the verdict on the system's effectiveness in treating pain - throughout a variety of surgical fields - varies between very effective in reducing post-operative pain and reducing overall narcotic consumption for several days to completely ineffective with no reported changes in perceived pain or overall narcotic use.

Through a randomized trial comparing plain saline to a common local anesthetic, The investigators hope to evaluate the effectiveness of these pain pumps as an outpatient modality for pain management following hemorrhoidectomy patients. The investigators hypothesize that there will be a significant benefit in pain relief with the use of these pumps.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients scheduled for hemorrhoidectomies at NMCP

排除标准

  • •Any patient with co-existing active purulent infection (i.e. abscess).
  • •Any patient who has had previous surgical intervention for his/her hemorrhoidal disease. Previous simple incision to treat a thrombosed hemorrhoid is not considered a surgical intervention for the purposes of this study. The minimal scar produced by a small incision would not alter post-operative pain following removal of a hemorrhoidal column.
  • •Any patient allergic to local anesthetics or oral pain medications
  • •Any patient with a history of chronic pain
  • •Any patient allergic to or has had an adverse reaction (i.e. history of gastrointestinal bleed) to a non-steroidal anti-inflammatory drugs (NSAIDs)
  • •Any patient pregnant patient

研究组 & 干预措施

Pump device

Placebo Comparator

One arm will have continuous subcutaneous infusion of normal saline.

干预措施: placement of a continuous infusion pump (Device)

Bupivacaine

Active Comparator

will receive continuous infusion of bupivacaine

干预措施: continuous infusion pump of bupivacaine (Device)

结局指标

主要结局

VAS pain scales

时间窗: 1 week

次要结局

未报告次要终点

研究者

发起方
United States Naval Medical Center, Portsmouth
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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